Learn more about how our IVD technical specialists can review and confirm your product’s readiness for market.
As a manufacturer of an in vitro diagnostic (IVD) medical device, you must ensure you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are outlined in the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 and, for the UK, the UK Medical Devices Regulations (UK MDR) 2002.
As an EU Notified Body and UK Approved Body our technical specialists have years of experience and can support you through the process of bringing your medical device on to the market.
It is important that you start your application early, so use this toolkit to access the key resources you need to prepare for your transition
This guide will help you identify the route to conformity
Find out how our technical specialists can support your IVD devices business
At BSI we offer training courses tailored to In-Vitro Diagnostics to help support and grow your business.